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← Jevtana: metastatic Prostate Cancer

NCT02489318 · STUDY IN CONTEXT

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.

Intent to treat (ITT) population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.

→

primary · POSTED

OS was defined as the time from date of randomization to date of death from any cause.

ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.

→

secondary · POSTED

Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.

ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.

→

secondary · POSTED

Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.

ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.

→

secondary · POSTED

Time to chronic opioid use was defined as the time from date of randomization to the first date of confirmed chronic opioid use. For participants entering the study without receiving opioids, chronic opioid use was defined as administration of opioid analgesics lasting for greater than or equal to (\>=) 3 weeks for oral or \>=7 days for non-oral formulations. For participants entering the study already receiving opioids, chronic opioid use was defined as a \>=30 percent (%) increase in total daily dose of the opioid analgesics lasting for \>= 3 weeks for oral or \>= 7 days for non-oral formulation.

ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.

→

secondary · POSTED

Time to SRE was defined as the time from the date of randomization to the date of the first observation of an SRE. A SRE was defined as the occurrence of either a pathological fracture, or spinal cord compression, or radiation to bone, or surgery to bone.

ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Brief Pain Inventory · Time to Pain Progression

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02489318
qol key
qol-0003
source section id
NCT02489318-om-0003
source outcome index
3
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Time to Pain Progression
measure definition
Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.
time frame
Up to 57 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02489318
trial label
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0000
    source section id
    NCT02489318-om-0000
    source outcome index
    0
    endpoint
    Radiographic Progression-free Survival (rPFS)
    endpoint definition
    rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.
    time origin
    Up to 35 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to treat (ITT) population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0001
    source section id
    NCT02489318-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS was defined as the time from date of randomization to date of death from any cause.
    time origin
    Up to 57 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0002
    source section id
    NCT02489318-om-0002
    source outcome index
    2
    endpoint
    Time to Initiation of Cytotoxic Chemotherapy
    endpoint definition
    Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
    time origin
    Up to 57 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0003
    source section id
    NCT02489318-om-0003
    source outcome index
    3
    endpoint
    Time to Pain Progression
    endpoint definition
    Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.
    time origin
    Up to 57 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0004
    source section id
    NCT02489318-om-0004
    source outcome index
    4
    endpoint
    Time to Chronic Opioid Use
    endpoint definition
    Time to chronic opioid use was defined as the time from date of randomization to the first date of confirmed chronic opioid use. For participants entering the study without receiving opioids, chronic opioid use was defined as administration of opioid analgesics lasting for greater than or equal to (\>=) 3 weeks for oral or \>=7 days for non-oral formulations. For participants entering the study already receiving opioids, chronic opioid use was defined as a \>=30 percent (%) increase in total daily dose of the opioid analgesics lasting for \>= 3 weeks for oral or \>= 7 days for non-oral formulation.
    time origin
    Up to 57 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0005
    source section id
    NCT02489318-om-0005
    source outcome index
    5
    endpoint
    Time to Skeletal-related Event (SRE)
    endpoint definition
    Time to SRE was defined as the time from the date of randomization to the date of the first observation of an SRE. A SRE was defined as the occurrence of either a pathological fracture, or spinal cord compression, or radiation to bone, or surgery to bone.
    time origin
    Up to 57 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Placebo + Androgen Deprivation Therapy (ADT)
    regimen
    Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    527
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Apalutamide + ADT
    regimen
    Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    525
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Placebo + Androgen Deprivation Therapy (ADT)
    regimen
    Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    527
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Apalutamide + ADT
    regimen
    Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    525
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Placebo + Androgen Deprivation Therapy (ADT)
    regimen
    Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    527
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Apalutamide + ADT
    regimen
    Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    525
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Placebo + Androgen Deprivation Therapy (ADT)
    regimen
    Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    527
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Apalutamide + ADT
    regimen
    Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    525
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Placebo + Androgen Deprivation Therapy (ADT)
    regimen
    Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    527
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Apalutamide + ADT
    regimen
    Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    525
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Placebo + Androgen Deprivation Therapy (ADT)
    regimen
    Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    527
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Apalutamide + ADT
    regimen
    Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    analyzed count
    525
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02489318-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    harm key
    EG000
    source section id
    NCT02489318-ae
    event group key
    EG000
    event group label
    Placebo + Androgen Deprivation Therapy (ADT)
    serious affected
    115
    serious at risk
    527
    other affected
    485
    other at risk
    527
    frequency threshold
    2
    collection period
    Up to 57 months
    event definition
    Safety Analysis set included all participants who received at least 1 dose of randomized study drug. Crossover participants were counted twice (in Placebo + ADT arm and in Placebo + ADT to Apalutamide + ADT arm) for safety analysis. For crossover participants, adverse events after initiation of crossover treatment were summarized separately in Placebo + ADT to Apalutamide + ADT arm. However, adverse events occurred before crossover treatment were summarized in Placebo + ADT arm.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    harm key
    EG001
    source section id
    NCT02489318-ae
    event group key
    EG001
    event group label
    Placebo + ADT to Apalutamide + ADT
    serious affected
    29
    serious at risk
    208
    other affected
    153
    other at risk
    208
    frequency threshold
    2
    collection period
    Up to 57 months
    event definition
    Safety Analysis set included all participants who received at least 1 dose of randomized study drug. Crossover participants were counted twice (in Placebo + ADT arm and in Placebo + ADT to Apalutamide + ADT arm) for safety analysis. For crossover participants, adverse events after initiation of crossover treatment were summarized separately in Placebo + ADT to Apalutamide + ADT arm. However, adverse events occurred before crossover treatment were summarized in Placebo + ADT arm.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    harm key
    EG002
    source section id
    NCT02489318-ae
    event group key
    EG002
    event group label
    Apalutamide + ADT
    serious affected
    153
    serious at risk
    524
    other affected
    494
    other at risk
    524
    frequency threshold
    2
    collection period
    Up to 57 months
    event definition
    Safety Analysis set included all participants who received at least 1 dose of randomized study drug. Crossover participants were counted twice (in Placebo + ADT arm and in Placebo + ADT to Apalutamide + ADT arm) for safety analysis. For crossover participants, adverse events after initiation of crossover treatment were summarized separately in Placebo + ADT to Apalutamide + ADT arm. However, adverse events occurred before crossover treatment were summarized in Placebo + ADT arm.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02489318
    qol key
    qol-0003
    source section id
    NCT02489318-om-0003
    source outcome index
    3
    instrument
    Brief Pain Inventory
    instrument basis
    matched 'brief pain inventory' in the study's own wording
    scale title
    Time to Pain Progression
    measure definition
    Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.
    time frame
    Up to 57 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice